Quality Assurance Specialist 3

Job description

As a Quality Assurance Specialist 3 within our Regulatory and Quality - Diagnostics team, you will be integral to ensuring the highest standards of compliance and operational excellence in our laboratory environment. Reporting to the Senior Manager, Quality Assurance, you will drive quality initiatives and maintain robust Quality Management Systems (QMS) that meet state, federal, and accrediting body requirements—including California, CLIA, CAP, and NYSDOH. Knowledge: - In-depth understanding of Quality Management System (QMS) requirements and regulatory frameworks such as CLIA, CAP, NYSDOH, and state/federal regulations. - Advanced knowledge of managing deviations, non-conformances, complaints, and Corrective and Preventive Actions (CAPA). - Familiarity with Laboratory Developed Tests (LDTs) in CAP-accredited and CLIA-certified environments. - Working knowledge of risk assessments, compliance audits, and quality improvement processes. - Experience with MediaLab and medical device quality system regulations is a plus. Skills: - Demonstrated ability to develop, implement, and enhance QMS for ongoing compliance with regulatory standards. - Proficient in administering quality programs...